Medical Safety Dir

Hace 2 días

Madrid, España IQVIA Jornada completa
Experteer Overview As Medical Safety Director, you lead pharmacovigilance activities across trials and safety projects, guided by management oversight. You provide global project leadership for multi-advisor efforts and mentor junior staff. You oversee medical reviews of safety data, drive regulatory document content, and represent safety findings in client meetings. You ensure on-time delivery of safety deliverables and maintain up-to-date awareness of regulatory developments. This role combines medical expertise with strategic safety leadership in a dynamic, hybrid work environment.
Compensaciones / Beneficios
- Perform medical review of trial-related AEs and ADRs, including causality, seriousness, and data verification
- Draft and review AOSEs for expedited cases per regulatory requirements
- Advise pharmacovigilance case processing teams as an internal consultant
- Provide aggregate safety data reviews to monitor product safety profile
- Review and code AEs, Past medical history, Concomitant medications for data accuracy
- Present safety findings in client meetings
- Review and edit safety reports (IND Annual Reports, EU PSPs, US PSURs, etc.)
- Oversee Development Risk Management Plans and EU/US risk management strategies
- Provide medical oversight for label development and changes
- Attend Data Safety Monitoring Board and Safety Monitoring Committee meetings
- Contribute to Integrated Safety Summary or CTD safety sections
- Review and sign off on Project Safety Plan and Medical Monitoring Plan
- Medical review of protocols, IDB, and CRFs for safety content
- Act as Global Safety Physician/Assistant/Back-up; lead medical safety projects
- Lead training, delivery, communication, and quality control for projects
- Ensure safety deliverables meet regulatory or contracted timelines
- Provide medical escalation support for safety projects and EU pharmacovigilance roles
- Provide 24-hour medical support on assigned projects
- Keep abreast of medical-safety-regulatory developments
- Participate in RFP reviews, budgeting, and bid defenses for medical safety services
- Attend client meetings to promote medical safety servicesResponsabilidades
- Medical degree (MD) from an accredited medical school
- Three years of clinical practice plus four years in pharmaceutical or related industry, or equivalent
- Knowledge of relevant regulations and guidelines for clinical research, pharmacovigilance, and GCP
- Understanding of clinical trials and pharmaceutical research processes
- Ability to set priorities, meet deadlines, and manage objectives
- Consultation and advisory skills across multiple assignments with initiative and flexibility
- Strong relationship-building with colleagues, managers, and clients
- Valid medical license or equivalent in the residing country/regionRequisitos principales
- hybrid work model
- collaborative culture
- opportunities across IT, data, AI, finance, HR
- career development and mentorship